The magnitude of change in PTH will be measured between Baseline and Week 48. The magnitude of change is the fold change compared to the baseline value. (If multiplied by 100 would be the percent change from baseline.)

Change from baseline, magnitude of most extreme fold change, and time to most extreme fold change from baseline in PTH, FGF23, 1,25-OHD, and TRP by race and baseline vitamin D status (25-OHD serum concentration).

The association between (1) the time to most extreme fold change and slope of the curve of baseline to most extreme fold change in urine and serum calcium and phosphate (SCa, UCa/UCr, SPO4, TRP) and (2) the time to most extreme fold change and slope of the curve of baseline to most extreme fold change in PTH, FGF23, 1,25-OHD.

Change from baseline, magnitude of most extreme fold change, and time to most extreme fold change, and slope of the curve of baseline to most extreme fold change in glomerular function (change in SCr from baseline) and renal tubular function (urine glucose (UGluc), URBP/UCr, UB2MG, UProt/UCr).

Association between (1) change from baseline, magnitude of most extreme fold change, time to most extreme fold change, and slope of the curve of baseline to most extreme fold change of TRP and (2) markers of renal tubular function (UGluc, URBP/UCr, UB2MG, UProt/UCr) and markers of endocrine change (PTH, FGF23).

Change from baseline, magnitude of most extreme fold change, time to most extreme fold change from baseline, and slope of the curve of baseline to most extreme fold change in markers of bone turnover (BAP, OC, CTX); association of these changes with endocrine controllers of calcium-phosphate balance (PTH, FGF23, 1,25-OHD), UCa/UCr, and TRP.

Association between (1) baseline values, changes from baseline, magnitude of most extreme fold change, and time to most extreme fold change from baseline, and slope of the curve of baseline to most extreme fold change for PTH, FGF23, 1,25-OHD, BAP, OC, CTX, SCr, UCa/UCr ratio, and TRP and (2) 25-OHD and 1,25-OHD serum concentrations.

Association between (1) the baseline values, magnitude of most extreme fold change, and time to most extreme fold change from baseline of the markers of bone turnover (BAP, OC, CTX) and endocrine controllers of calcium-phosphate balance (PTH, FGF23, 1,25-OHD) to the baseline values and (2) the magnitude of change in BMD/BMC from baseline to weeks 24 and 48.

For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).

Change from baseline, magnitude of most extreme fold change, and time to most extreme fold change from baseline in PTH, FGF23, 1,25-OHD, and TRP by race and baseline vitamin D status (25-OHD serum concentration).

The association between (1) the time to most extreme fold change and slope of the curve of baseline to most extreme fold change in urine and serum calcium and phosphate (SCa, UCa/UCr, SPO4, TRP) and (2) the time to most extreme fold change and slope of the curve of baseline to most extreme fold change in PTH, FGF23, 1,25-OHD.

Change from baseline, magnitude of most extreme fold change, and time to most extreme fold change, and slope of the curve of baseline to most extreme fold change in glomerular function (change in SCr from baseline) and renal tubular function (urine glucose (UGluc), URBP/UCr, UB2MG, UProt/UCr).

Association between (1) change from baseline, magnitude of most extreme fold change, time to most extreme fold change, and slope of the curve of baseline to most extreme fold change of TRP and (2) markers of renal tubular function (UGluc, URBP/UCr, UB2MG, UProt/UCr) and markers of endocrine change (PTH, FGF23).

Change from baseline, magnitude of most extreme fold change, time to most extreme fold change from baseline, and slope of the curve of baseline to most extreme fold change in markers of bone turnover (BAP, OC, CTX); association of these changes with endocrine controllers of calcium-phosphate balance (PTH, FGF23, 1,25-OHD), UCa/UCr, and TRP.

Association between (1) baseline values, changes from baseline, magnitude of most extreme fold change, and time to most extreme fold change from baseline, and slope of the curve of baseline to most extreme fold change for PTH, FGF23, 1,25-OHD, BAP, OC, CTX, SCr, UCa/UCr ratio, and TRP and (2) 25-OHD and 1,25-OHD serum concentrations.

Association between (1) the baseline values, magnitude of most extreme fold change, and time to most extreme fold change from baseline of the markers of bone turnover (BAP, OC, CTX) and endocrine controllers of calcium-phosphate balance (PTH, FGF23, 1,25-OHD) to the baseline values and (2) the magnitude of change in BMD/BMC from baseline to weeks 24 and 48.

For subjects in the extension phase of the study, the last measured values at the ATN 110 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 study week 48 visit).

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Renal, Endocrine, and Bone Changes in Response to FTC/TDF in Uninfected Young Men Who Have Sex With Men (YMSM).

Official Title ICMJE

Renal, Endocrine, and Bone Changes in Response to Treatment With Coformulated Emtricitabine-Tenofovir for Pre-Exposure HIV Prophylaxis (PrEP) in HIV Uninfected Young Men Who Have Sex With Men. Sub-Study of Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 110 and/or ATN 113

Brief Summary

This is a prospective observational cohort sub-study of subjects enrolled in ATN 110 or ATN 113, which is a prospective interventional trial.

Detailed Description

This is a prospective observational cohort sub-study of subjects enrolled in the ATN 110 or ATN 113 study. All subjects will be followed for at least 48 weeks. Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase of ATN 110 or ATN 113 and ATN 117. The maximum duration of participation will be 96 weeks.

There is no therapeutic intervention specific to this sub-study, and there are no extra study visits required for participation in this sub-study. Questionnaires will be administered and blood and urine samples for laboratory evaluation of potential emtricitabine (FTC)/tenofovir (TDF) (Truvada®) toxicities will be obtained for this sub-study at visits that are required by the ATN 110 or ATN 113 study. Measurement of bone mineral density (BMD) and bone mineral content (BMC) by dual-energy X-ray absorptiometry (DXA) scan are planned as a part of the ATN 110 and ATN 113 studies, and results will be utilized for the analysis in this study. This study does not require extra BMD or BMC measurements.

Individuals between the ages 15 years 0 days to 22 years 364 days, who are enrolled in ATN 110 or ATN 113, and agree to enter this sub-study at the same time they begin ATN 110 or ATN 113.

Condition ICMJE

HIV Infection

Intervention ICMJE

Drug: FTC/TDF (Truvada®)

There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.

Other Name: Truvada®

Study Group/Cohort (s)

Subjects Enrolled in ATN 110 or ATN 113

A subset of 100 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.

Intervention: Drug: FTC/TDF (Truvada®)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.